There’s more tur­moil to re­port from in­side No­var­tis’ CAR-T camp.

On Fri­day Karen Walk­er will leave a se­nior po­si­tion in charge of CMC/man­u­fac­tur­ing of CAR-Ts for No­var­tis in ex­change for a new po­si­tion she’s tak­ing at Seat­tle Ge­net­ics, End­points News has learned.

Walk­er — the VP Glob­al Head Cell and Gene Ther­a­pies Tech­ni­cal De­vel­op­ment and Man­u­fac­tur­ing at No­var­tis — was one of three se­nior ex­ecs put in charge of the cell and gene ther­a­py ini­tia­tive at the com­pa­ny last fall, ac­cord­ing to sources close to the com­pa­ny, af­ter a bruis­ing re­struc­tur­ing over the sum­mer in which the unit was chopped up and ab­sorbed in­side a huge R&D or­ga­ni­za­tion. Samuele Butera was put in charge of the com­mer­cial/busi­ness as­pect of the group while David Leb­wohl han­dles clin­i­cal ops.

“Karen Walk­er will join Seat­tle Ge­net­ics as Vice Pres­i­dent of Glob­al Qual­i­ty in mid-April,” con­firmed a spokesper­son for Seat­tle Ge­net­ics.

I con­tact­ed Er­ic Al­thoff, a spokesper­son for No­var­tis, Wednes­day night, but af­ter ac­knowl­edg­ing my query he did not fol­low up. Al­thoff has de­clined to re­spond to a fol­lowup query.

No­var­tis has been bleed­ing tal­ent through­out its glob­al or­ga­ni­za­tion for the past year. Walk­er’s de­par­ture, though, comes at a par­tic­u­lar­ly crit­i­cal stage for No­var­tis, just days af­ter the phar­ma gi­ant gained a pri­or­i­ty re­view for CTL019, putting it on a short path to per­haps the first his­toric ap­proval for a CAR-T.

Last sum­mer End­points broke the sto­ry about No­var­tis’ re­or­ga­ni­za­tion in CAR-T, which led the group’s top ex­ec, Us­man ‘Oz’ Azam, to leave No­var­tis. About 120 staffers were al­so ter­mi­nat­ed as the sep­a­rate group was pulled back in­to the R&D struc­ture.

No­var­tis has kept up a neck-and-neck race with Kite on the lead pro­gram, which has its own pi­o­neer­ing CAR-T head­ed to the FDA.

Man­u­fac­tur­ing in this field is crit­i­cal. To make this ther­a­py, physi­cians ex­tracts cells from can­cer pa­tients and then reengi­neer them with a chimeric anti­gen re­cep­tor to guide them to at­tack can­cer cells. The re­vised cells are then in­ject­ed back in­to pa­tients. To be com­pet­i­tive, a com­pa­ny has to prove not on­ly that they know how to make the ther­a­py, they al­so have to be able to turn it around quick­ly for use.

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.